The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Primeline Container Ltd..
| Device ID | K073168 |
| 510k Number | K073168 |
| Device Name: | AESCULAP PRIMELINE CONTAINER LTD. |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-09 |
| Decision Date | 2008-04-28 |
| Summary: | summary |